Acute Ischemic Stroke study: TAK-755
Official title A Study of TAK-755 in Adults With Acute Ischemic Stroke
ClinicalTrials.gov ID: NCT07392450
What this study is testing
What is TAK-755?
an investigational IV infusion being studied as a potential treatment for acute ischemic stroke is designed to replace the missing ADAMTS13 enzyme and help break down large von Willebrand factor multimers that can contribute to clot formation
Also referred to as rADAMTS13.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if TAK-755 is safe and well‑tolerated, and to explore whether it improves daily activities or reduces stroke severity compared with placebo.
- Who it's for
- Adults who have recently experienced an acute ischemic stroke.
- What's involved
- Participants receive one dose of TAK-755 or a matching placebo, continue their usual stroke care, and undergo health checks and questionnaires for about 90 days.
- Time commitment
- Approximately three months of follow‑up, including visits and monitoring after the single dose.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinical diagnosis of AIS.
- Onset of stroke symptoms within 24 hours of randomization. Wake-up strokes may be included if Last Known Well is within 24 hours of randomization
- Complete hemianopia (NIHSS visual score \>=2).
- Aphasia impairing meaningful communication (NIHSS language score \>=2).
- Motor deficit with inability to sustain effort against gravity (NIHSS left or right motor arm or leg score \>=2).
You likely can't join if
- Weight \>130 kilograms (kg) or \<40 kg.
- History of severe traumatic brain injury in the past 90 days.
- History of intracranial hemorrhage.
- History of intracranial neoplasm except for small meningioma.
- History of prior stroke in the past 90 days.
- History of intracranial or intraspinal surgery within the past 90 days.
See the full eligibility criteria
- Clinical diagnosis of AIS.
- Onset of stroke symptoms within 24 hours of randomization. Wake-up strokes may be included if Last Known Well is within 24 hours of randomization; time of onset will be considered the time of Last Known Well.
- Complete hemianopia (NIHSS visual score \>=2).
- Aphasia impairing meaningful communication (NIHSS language score \>=2).
- Motor deficit with inability to sustain effort against gravity (NIHSS left or right motor arm or leg score \>=2).
- Estimated Modified Rankin Scale score less than (\<) 2 prior to AIS presentation, signifying no significant disability.
- Evidence of causative AIS occlusions affecting supratentorial circulation on imaging (intracranial internal carotid artery [ICA], middle cerebral artery [MCA; M1 - M4], anterior cerebral artery [ACA
- Evidence of salvageable brain tissue on CT or MR imaging.
- Weight \>130 kilograms (kg) or \<40 kg.
- History of severe traumatic brain injury in the past 90 days.
- History of intracranial hemorrhage.
- History of intracranial neoplasm except for small meningioma.
- History of prior stroke in the past 90 days.
- History of intracranial or intraspinal surgery within the past 90 days.
- Major surgery or severe trauma in the past 14 days.
- History of cerebral amyloid angiopathy.
- Recent history of active systemic malignancy within the last 5 years, except for locally excised basal cell or squamous cell skin carcinoma with clear margins.
- Diagnosis of serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year.
- Participation in other treatment clinical trials within the previous 90 days.
- Known life-threatening hypersensitivity reaction to TAK-755 or its components.
- Any prior administration of TAK-755.
- Administration of caplacizumab in the past 30 days.
- Administration of von Willebrand factor-containing products in the past 14 days.
- Any prior administration (intravenous or intra-arterial) of alteplase or tenecteplase for the index AIS event, as well as any prior administration of prourokinase or reteplase for the index AIS event in countries where...
- Eligible for administration of intravenous thrombolysis (alteplase or tenecteplase, as well as prourokinase or reteplase in countries where approved) for the index AIS event, based on the site's standard clinical...
- Intent to proceed with endovascular thrombectomy (EVT) for the index AIS event based on eligibility and direct availability.
- Seizure at time of index AIS event onset, only if it precludes accurate assessment of baseline NIHSS.
- Persistent blood pressure elevation (systolic \>=185 millimeters of mercury [mmHg] or diastolic \>=110 mm Hg) prior to randomization.
- Active, uncontrolled bleeding.
- Bleeding diathesis or any other conditions that would pose significant bleeding risk.
- Inability to undergo MRI or CT.
- Chronic causative intracranial occlusion.
- Causative total occlusion of the extracranial ICA.
- Evidence of septic emboli or bacterial endocarditis.
- Another clinically significant concomitant disease that may pose additional risks for the participant in the opinion of the investigator.
- Poor quality imaging that precludes interpretation according to trial protocol.
- Evidence of significant intracranial mass effect or midline shift.
- Evidence of acute occlusion in \>1 vascular territory (right/left MCA, right/left ACA, right/left PCA); multiple occlusions within the same vascular territory are allowed.
- Evidence of acute or chronic intracranial hemorrhage (presence of chronic cerebral microbleeds on magnetic resonance imaging [MRI]) T2\ -weighted type sequence (such as gradient recalled echo [GRE] or susceptibility...
- Evidence of extensive early ischemic change estimated to be greater than one-third of the middle cerebral artery territory or evidence of well-demarcated hypoattenuation on computed tomography (CT), if performed...
- Identification by the investigator as being potentially unable or unwilling to cooperate with trial procedures.
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Porto Alegre, Rio Grande do Sul, Brazil
- Beijing, Beijing Municipality, China
- Nanyang, Henan, China
- Xuzhou, Jiangsu, China
- Jinan, Shandong, China
- Liaocheng, Shandong, China
- Linyi, Shandong, China
- Datong, Shanxi, China
- Linfen, Shanxi, China
- Fukuoka, Fukuoka, Japan
- Nagano, Nagano, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Porto Alegre, Rio Grande do Sul, Brazil; Beijing, Beijing Municipality, China; Nanyang, Henan, China; Xuzhou, Jiangsu, China; Jinan, Shandong, China and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.